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ISRCTN
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ISRCTN39708525
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of the use of the Foley catheter balloon for induction of labour to reduce the incidence of caesarean section in diabetic pregnancies: a prospective clinical, economic and psychological evaluation
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0236180646
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Study hypothesis
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1. To establish if Foley catheter balloon cervical dilatation can improve the rates of successful induction of labour in insulin-dependent pregnant diabetic women, and thereby reduce caesarean section rates.
2. To establish whether there is an increase in satisfaction with labour and outcome in women who undergo this new method of inducing labour.
3. To establish whether there are any economic advantages to this new method of induction of labour
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Pregnancy and Childbirth: Labour induction
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Women will be excluded if they are planning an elective caesarean delivery, are multiparae, have co-existing other medical disorders, multiple pregnancy, breech or any presentation other than cephalic.
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Anticipated start date
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01/11/2003
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Anticipated end date
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01/05/2006
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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40 women should be recruited to each group - 80 women in total.
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Interventions
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Women consenting to participate in the trial will be randomly allocated to one of two groups:
1. Women will be induced at 38 weeks gestation by means of vaginal prostaglandins according to our current labour ward protocol.
2. 24 hrs before planned induction of labour, a Foley balloon catheter will be inserted through the cervical canal and inflated to 30ml, and left in situ for 24 hrs, or until it drops out when the cervix has dilated to 4cm+, which ever occurs earlier. Labour is then induced as per protocol used in women in group 1.
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Primary outcome measure(s)
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Vaginal delivery versus caesarean section.
1. Clinical: induction success rates, caesarean section rates, length of labour, instrumental delivery, blood loss and neonatal outcomes including Apgar scores, admission to SCBU and blood glucose levels.
2. Psychological: maternal satisfaction rates assessed by a designer questionnaire.
3. Economic: basic costs assessment, including the costs of Foley catheters, additional 24 hour hospital stay, costs of caesarean section etc.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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St George's Healthcare NHS Trust (UK)
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mr
Isaac Tainzana
Manyonda
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Address
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Obstetrics Dept
Lanesborough Wing
St George's Hospital
Blackshaw Road, Tooting
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City/town
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London
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Zip/Postcode
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SW17 0QT
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Country
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United Kingdom
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Tel
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+44 020 8725 3771
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Fax
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+44 020 8725 5958
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Email
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i.manyonda@sghms.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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21/08/2008
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Date ISRCTN assigned
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28/09/2007
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